[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494204":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":45,"locations":53,"responsibleParty":84,"collaborators":26,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":26,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":26,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":110,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"GPi-DBS","EXPERIMENTAL","The DBS electrodes are implanted into posteroventral GPi bilaterally.",[13,14],"Procedure: GPi-DBS","Device: GPi-DBS devices",{"label":16,"type":10,"description":17,"interventionNames":18},"STN-DBS","The DBS electrodes are implanted into dorsolateral STN bilaterally.",[19,20],"Procedure: STN-DBS","Device: STN-DBS devices",[22,27,30,35],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","An elaborate target\u002Ftrajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 1.5mm) will be inserted into the posteroventral part of bilateral GPi nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left\u002Fright subclavicular area subcutaneously.",[9],null,{"type":23,"name":16,"description":28,"armGroupLabels":29,"otherNames":26},"An elaborate target\u002Ftrajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 0.5mm) will be inserted into the dorsolateral part of bilateral STN nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left\u002Fright subclavicular area subcutaneously.",[16],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"DEVICE","GPi-DBS devices","1. DBS electrode: 3387 (Medtronic, Minneapolis, MN, USA) or L302 (PINS Medical, Beijing, China) or 1210(SceneRay, Suzhou, China);\n2. Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340\u002FSR1341 (SceneRay, Suzhou, China);\n3. Implantable pulse generator: ACTIVA PC\u002FRC (Medtronic, Minneapolis, MN, USA) or G102\u002FG102R (PINS Medical, Beijing, China) or 1180\u002FSR1101 (SceneRay, Suzhou, China).",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":26},"STN-DBS devices","1. DBS electrode: 3389 (Medtronic, Minneapolis, MN, USA) or L301 (PINS Medical, Beijing, China) or 1200 (SceneRay, Suzhou, China);\n2. Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340\u002FSR1341 (SceneRay, Suzhou, China);\n3. Implantable pulse generator: ACTIVA PC\u002FRC (Medtronic, Minneapolis, MN, USA) or G102\u002FG102R (PINS Medical, Beijing, China) or 1180\u002FSR1101 (SceneRay, Suzhou, China).",[16],[40,43],{"name":41,"affiliation":5,"role":42},"Zhiqi Mao, PhD","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":5,"role":42},"Bin Liu, MD",[46,50],{"name":41,"role":47,"phone":48,"phoneExt":26,"email":49},"CONTACT","8618910155994","markmaoqi@126.com",{"name":44,"role":47,"phone":51,"phoneExt":26,"email":52},"8618561812781","liubinsdu@163.com",[54],{"facility":5,"status":26,"city":55,"state":26,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Beijing","100853","China","CN",{"type":60,"coordinates":61},"Point",[62,63],116.39723,39.9075,{"lat":63,"lon":62},[66,68,69,70,71,74,76,78,80,82],{"name":67,"role":47,"phone":48,"phoneExt":26,"email":49},"Zhiqi Mao, Ph.D",{"name":44,"role":47,"phone":51,"phoneExt":26,"email":52},{"name":67,"role":42,"phone":26,"phoneExt":26,"email":26},{"name":44,"role":42,"phone":26,"phoneExt":26,"email":26},{"name":72,"role":73,"phone":26,"phoneExt":26,"email":26},"Rui Hui, MD","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":26,"phoneExt":26,"email":26},"Jie Meng, MD",{"name":77,"role":73,"phone":26,"phoneExt":26,"email":26},"Di Liu, MD",{"name":79,"role":73,"phone":26,"phoneExt":26,"email":26},"Shufeng Liang, MD",{"name":81,"role":73,"phone":26,"phoneExt":26,"email":26},"Zhebin Feng, MD",{"name":83,"role":73,"phone":26,"phoneExt":26,"email":26},"Jun Hong, MD",{"type":42,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Zhiqi Mao","Professor","100494204","comparison-of-pallidal-with-subthalamic-deep-brain-stimulation-for-cervical-dystonia-100494204",false,"NCT05715138","Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia","A Randomized Controlled Trial Comparing PAllidal and SubThalamic Deep Brain Stimulation for Cervical Dystonia（the PASTS-CD Study）","Inclusion criteria\n\n1. Diagnosed as idiopathic or hereditary isolated CD;\n2. Severe functional impairment;\n3. Oral medication and injection of botulinum toxin become ineffective (\\> 3 months since last injection), or refuse to adopt botulinum toxin injection;\n4. No secondary causes of CD;\n5. Age 18-80 years old;\n6. Normal neurological examination except for dystonia;\n7. Normal brain MRI;\n8. The subject or their family members can fully understand the trial and sign the informed consent;\n9. Good compliance and willingness to receive regular follow-ups.\n\nExclusion criteria\n\n1. Diagnosed as secondary CD;\n2. CD with obvious trunk\u002Flimb involvement, or Meige syndrome;\n3. History of severe mental disorders, dementia, or epilepsy;\n4. Previous dystonia surgery (pallidotomy, thalamotomy, DBS, etc);\n5. Accompanied by other neurological diseases (Parkinson's disease, essential tremor, multiple sclerosis, stroke, etc);\n6. The patient has or needs other implantable devices (cardiac pacemakers, defibrillators, cochlear implants, spinal cord stimulators, etc);\n7. Pregnant women or women who are waiting to become pregnant during the trial;\n8. Poor health condition.","ALL","18 Years","80 Years",{"count":98,"type":99},98,"ESTIMATED","INTERVENTIONAL",[102],"NA","Cervical dystonia (CD), also known as spasmodic torticollis, is a type of focal dystonia, mainly manifesting as involuntary head turning or tilting, or holding a twisted posture. Although it can be alleviated by injection of botulinum toxin, the effect is temporary so that patients require multiple injections. Deep Brain Stimulation (DBS) targeting on globus pallidus internus (GPi) or subthalamic nucleus (STN) has been proved to be a safe and effective strategy for primary cervical dystonia, even for those medically refractory cases. However, the question of which target is better has not been clarified.\n\nTherefore, the invstigators design this randomized and controlled trial, aiming to compare the differences between GPi-DBS and STN-DBS for cervical dystonia in the improvement of symptoms , quality of life, mental status, cognitive status, as well as in stimulation parameters and adverse effects. The invstigators hypothesize that STN-DBS will outperform GPi-DBS at short-term follow-up, while the superiority will disappear and the efficacy of the two group will become similar at long-term follow-up.",[105],"Cervical Dystonia",[107,108,109],"globus pallidus internus","subthalamic nucleus","deep brain stimulation","NOT_YET_RECRUITING","2023-07-19",{"date":113,"type":114},"2023-07-21","ACTUAL",{"date":116,"type":99},"2023-09-01",{"date":118,"type":99},"2026-11-30",{"name":5,"class":6},1]